JPH023611A - Method for manufacturing a solid composition of lacturose and a composition obtained by this method - Google Patents

Abstract

PURPOSE: To prepare the subject composition, useful for treating chronic constipation and hepatic coma by mixing a lactulose syrup with Fiberform (R), spreading the resultant mixture, drying the spread mixture, crushing the dried mixture and optionally sieving the crushed mixture. CONSTITUTION: A 50% lactulose syrup is mixed with Fiberform (R) in an amount of 150-35 g, preferably 200-300g based on 1L syrup (a dietary fiber product, having >80wt.% fiber content and based on husks of grains) and the mixture is then mixed for several min, subsequently spread and dried at 60-90 deg.C for several hr, crushed and, as necessary, sieved to a desired particle size to provide a solid composition for administering the lactulose.

Description

DETAILED DESCRIPTION OF THE INVENTION The present invention relates to a method for producing a solid composition for administration of laculose and a composition obtained by this method.

It is known that lactulose, the isomerization product of lactose, is particularly suitable for the treatment of chronic constipation and hepatic coma, among others. Typically, laculose in the form of a 50% aqueous solution of laculose is used. However, the use of laculose in the form of such a syrup is far from ideal.

Furthermore, the use of laculose in crystalline form is known. However, the method of crystallization of laculose is particularly laborious.

After Q, British Patent Application No. 2,156,196 relates to therapeutic or dietary compositions comprising vegetable fibers and lactulose. The two components should exhibit strong opposing synergistic effects. The plant fiber or dietary fiber used in this Mll animal is ``raw fiber'', an ``active'' fiber of 1
Contains 11-22% fibers known as fibres. With a number of other ingredients, this known three-part composition can be processed into dietary products, especially in the form of biscuits.

It is an object of this invention to provide a ready-to-use solid KLI formulation for lactulose administration. ! ! The goal is to provide a method for creating a product.

It has been found that a solid composition for lactulose administration can be obtained by adding lactulose syrup onto a hygroscopic textile as a carrier for lactulose syrup. It has been found that the previously used pharmaceutical ingredients, such as aerosols, lactose and all'Oa, are not suitable for this purpose.

Also, plant fiber ♀ II! The material (ie raw fiber) also cannot be used as a hygroscopic carrier for the manufacture of solid compositions for administration of laculose.

A dietary fiber product based on the husk of grains with a fiber content of greater than 80%, known as Fiberform, converts lactulose syrup into a suitable solid S composition for lactulose administration. It has been found in particular that it can be used very well as a carrier material for production in a simple manner. Fiberforms are used as agents to control intestinal activity. It is produced from wheat bran (
A granulate of a modified fiber concentrate made from wheat bran. 1st stage (protein hydrolysis)
The protein content is reduced by proteinases. In the second stage (starch digestion) the product is treated with amylase to remove virtually all starch.

In the third stage (phytic acid removal), the naturally occurring enzyme phytose is activated to break down over 90% of the phytic acid, which is known to combine with essential minerals like iron, zinc, calcila-11 and magnesium. Remove.

The resulting granulate has standardized and reproducible pharmaceutical properties.

The solid composition for lactulose administration according to the invention is obtained in a simple manner by mixing lactulose syrup with a fiber foam carrier material, spreading the mixture, drying, crushing and optionally sieving to the desired particle size.

A preferred starting material is a syrup containing about 50% solid lactulose. 150-350 g of fiber foam per liter of this syrup, especially 200-30 g
A 0g star is used. Mix the mixture for a few minutes and spread it on a stainless steel plate. After drying for several hours at a temperature of 60 to 90 °C, preferably about 80 °C, the product obtained is crushed, for example in a vibratory granulator, and after Q, if necessary, sieved to the desired particle size. .

The production of a solid one-part composition of lactulose according to the invention does not require any other auxiliary substances, which is an advantage for pharmaceutical products.

It is quite surprising that a solid composition for administration of laculose can be prepared in such a simple manner.

■ 7.5 kg of dietary fiber product Fiberform was added to a lactulose solution (Duphalac) ■32
kg and cole te
Mixed for 5 minutes in a mini-zer. Spread the mixture into 20 sheets.
6. Distribute onto a sealed drying plate and inlet air at 100 °C.
Dry for an hour. After drying for 2 and 4 hours, respectively, the clumps were loosened. The dry mass was transferred to a Frewi LL 12ran granulator (Frewi LL 12ran) with a sieve grid of 5 mm.
ulator).

Claims (1)

Claims: 1. A process for producing a solid composition of lactulose, characterized in that lactulose syrup is mixed with a high fiber product fiber foam, the mixture is spread, dried, crushed and optionally sieved. 2. Process according to claim 1, characterized in that 50% lactulose syrup is mixed with fiber foam in an amount of 150 to 350 g per liter of syrup. 3. Lactulose syrup 200-300 per liter
3. The manufacturing method according to claim 2, wherein the fiber foam of g. 4. The mixture of lactulose syrup and fiber foam is mixed for several minutes, spread, dried at 60-90°C for several hours, and the solid product is crushed and optionally sieved. The manufacturing method described in. 5. The manufacturing method according to claim 4, wherein drying is performed at 80° C. for 6 hours. 6. A solid composition of lactulose and fiber foam obtained according to the production method according to any one of claims 1 to 5.